Submission Details
| 510(k) Number | K192818 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 01, 2019 |
| Decision Date | March 31, 2020 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
Mar 2020
Decision
182d
Days
Class 2
Risk
About This 510(k) Submission
K192818 is an FDA 510(k) clearance for the Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System, a Bone Cement, Posterior Screw Augmentation (Class II — Special Controls, product code PML), submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on March 31, 2020, 182 days after receiving the submission on October 1, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.
Device Classification
| Product Code | PML — Bone Cement, Posterior Screw Augmentation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3027 |
| Definition | The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct. |
Manufacturer
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